India mulls adopting international standards on drug inspections, manufacturing

Print 29 April 2015
EJ Lane / FeircePharmaAsia

India's pharmaceutical regulators are considering whether to take the rigid steps necessary to join international drug inspection systems. The actions are considered necessary if India is to become more of an exporting nation, but some pharmas are cautious.

The Commerce Ministry invited stakeholders to discuss the idea of joining the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme, together known as PIC/S with Switzerland headquarters. Forty-five nations are members of the organization.

India, particularly under Prime Minister Narendra Modi and his "Make in India" program, has long contemplated encouraging the nation to become more of an exporting country and less of an importing one, including in pharmaceuticals.

To make that leap, however, the PIC/S members in particular are somewhat leery about India's drug production system and require it to comply with stronger regulations before allowing its wares on their local markets. Thus the Commerce Ministry's interest in meeting PIC/S standards and joining the group.

Although that might appear to be ideal for Indian drugmakers, the small and medium ones have raised concerns that adhering to the tough international standards would impose a hardship on them by increasing their costs of compliance. That, they fear, would rob them of the ability to keep their prices low, their main selling point abroad.

As those and even the large Indian pharmas have found, however, the mainly developed world is making it harder for them to sell those drugs on their markets. Many of the largest Indian drugmakers have shuttered production plants after they were caught short in complying with accepted standards.

Among the matters expected to be discussed as officials weigh the pros and cons are studies the government asked various groups to perform in advance. One was by the Pharmaceuticals Export Promotion Council on the impact of making a move toward PIC/S. Pharmexcil recently submitted a draft to Commerce.

The consideration has become particularly timely since PIC/S itself is considering an expansion of its rule beyond inspections of production to good clinical and good pharmacovigilance practices, broadening the number of standards India drug exporters would have to meet.

P.V. Appaji, Pharmexcil's director general, told the Economic Times the impact already was being felt as PIC/S members insist on compliance with their standards when placing government orders. He said even small countries without regulatory expertise are insisting on PIC/S compliance.

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